Galluzzo Marco, Tofani Lorenzo, Lombardo Paolo, Petruzzellis Alessandra, Silvaggio Dionisio, Egan Colin Gerard, Bianchi Luca, Talamonti Marina
Dermatology Unit, Fondazione Policlinico, "Tor Vergata", 00133 Rome, Italy.
Department of Experimental Medicine, University of Rome "Tor Vergata", 00133 Rome, Italy.
J Clin Med. 2020 Jul 9;9(7):2170. doi: 10.3390/jcm9072170.
Little information is available from real-life studies evaluating the efficacy of guselkumab in moderate-to-severe psoriasis. In this real-life study, we retrospectively examined a database of 52 patients with moderate-to-severe psoriasis treated with guselkumab (100 mg, s.c.) and followed for 1 year. Disease severity and treatment response was assessed by the Psoriasis Area and Severity Index (PASI) at baseline and after 4, 12, 20, 28, 36, 44, and 52 weeks. Predictors of a PASI response were evaluated by univariate and multivariate regression. After 12 months, 84.2% of patients (mean age 51.3 ± 14.1 years) treated with guselkumab achieved a PASI score of <3. Furthermore, PASI score decreased from 20 ± 13.3 at baseline to 4.4 ± 4.7 and 2.7 ± 3.9 at 12 and 20 weeks, and PASI 75, 90, and 100 response was achieved in 84.2%, 78.9%, and 63.2% of patients respectively at 12 months. Stepwise multivariate regression analysis revealed that previous biological treatment and the presence of comorbidities were associated with poorer response between 28-44 weeks, however the presence of obesity was not associated with poorer response. Difficult-to-treat areas were also improved as early as 12 weeks following guselkumab. Guselkumab was observed to be effective and safe in patients with moderate-severe chronic psoriasis in a real world-setting.
关于评估古塞库单抗治疗中重度银屑病疗效的真实世界研究,可获取的信息较少。在这项真实世界研究中,我们回顾性检查了一个数据库,该数据库包含52例接受古塞库单抗(100mg,皮下注射)治疗的中重度银屑病患者,并对其进行了1年的随访。在基线以及第4、12、20、28、36、44和52周时,通过银屑病面积和严重程度指数(PASI)评估疾病严重程度和治疗反应。通过单变量和多变量回归评估PASI反应的预测因素。12个月后,接受古塞库单抗治疗的患者中有84.2%(平均年龄51.3±14.1岁)达到PASI评分<3。此外,PASI评分从基线时的20±13.3降至第12周和第20周时的4.4±4.7和2.7±3.9,在12个月时分别有84.2%、78.9%和63.2%的患者实现了PASI 75、90和100反应。逐步多变量回归分析显示,既往生物治疗和合并症的存在与28 - 44周之间较差的反应相关,然而肥胖的存在与较差的反应无关。早在使用古塞库单抗12周后,难治性区域也得到了改善。在真实世界环境中,观察到古塞库单抗对中重度慢性银屑病患者有效且安全。